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510(k) K213861

CER-S by Cardiocalm Srl — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2022
Date Received
December 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Cardiocalm Srl

  • K243312 — CER-S (February 20, 2025)
  • K193177 — CER-S (August 26, 2020)

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  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)